Medical Devices Regulatory Services
in India

Overview

India is counted as one of the top global Medical Device markets with its major contribution from device imports. The Central Drug Standard Control Organization (CDSCO) regulates medical devices and In-Vitro Diagnostics (IVD) marketed in India. The CDSCO is headed by Drug Controller General of India (DCGI) and the approval authority is shared between Center Licensing Authority (CLA) and the State Licensing Authority (SLA).

Regulatory Authority: Central Drug Standard Control Organization (CDSCO)

Regulation: Medical Device Rules, 2017

Regulatory Pathway: Device Listing or Registration

Authorized Representative: Indian Authorized Agent (IAA) required for both Notified and Non-notified devices

QMS Requirement: Schedule 5 of MDR 2017/ ISO 13485:2016

Assessment of Technical Data: CDSCO or Notified bodies accredited by CDSCO

Validity of License: Unlimited

Labeling Requirements: Chapter VI of MDR 17, Legal Metrology Act

Submission Format: Online

Language: English

The Indian Medical Device Regulations are dynamic and are being made more stringent day by day. There are 37 categories of devices that are currently notified and regulated by the CDSCO in India. More device categories are being brought into purview of the CDSCO regulation in coming years. The Regulatory landscape in India is depicted as below:

India Medical Device Classification

Separate classification systems exist for Medical Devices and Invitro Diagnostic Devices (IVD). Each of these categories are classified into 4 classes based on the extent of risk associated with these devices.

Device Class

Risk

A

Low Risk

B

Low Moderate Risk

C

Moderate – High Risk

D

High Risk

Indian Authorized Agent (IAA)

Foreign manufacturers should appoint an Indian Authorized Agent (IAA) to market devices in India. The IAA shall possess active wholesale drug license in the 20B & 21B application forms. Foreign manufacturers may appoint their distributors or importers as the IAA. However, having an independent IAA, with no commercial interest, would provide required flexibility to appoint multiple distributors in India.

India Medical Device Registration

All the applications for both Notified and Non-notified devices must be submitted through online portal called SUGAM and the CDSCO manages the applications through the same portal.

Non-Notified Devices: The devices not included in the list of Notified Devices are not regulated in India. However, these devices shall be listed in the CDSCO portal. Foreign manufacturers shall have an IAA based in India to market these devices.

Notified Devices: There are 37 categories of devices listed in Notified list, which are regulated by the CDSCO and require prior approval from the CDSCO for marketing them in India. There are different types of application forms and the documentation requirements vary with the application form submitted to the CDSCO.

The choice of application varies based on the home country approval, availability of Free Sale Certificate (FSC), nature of applicant, operations, and the type of device. After detailed evaluation of applications, the CDSCO issues licenses for either testing, import or for manufacturing of devices.

Intended Operation

Indian Manufacturer (own Mfg. Site)

Indian Manufacturer (Others Site)

Foreign Manufacturer

Device manufacturing for distribution or sales

Manufacturing License

Loan License

NA

Device manufacturing/ Importation for Testing purpose

Test License

Test License

Test License

Device Importation for distribution in India (with reference country approval)

NA

NA

Import License without SEC Technical Assessment

Device Importation for distribution in India (without reference country approval / FSC)

NA

NA

Import License with SEC Technical Assessment

Process flow

Post Approval Device Life Cycle Management

Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

· Post approval change management - modifications to existing Medical Device approvals such as, addition of new variants, accessories; addition of new indications of use among others

· Maintenance of approvals and registration through timely payment of administrative and registration fees

· Renewal of licenses

· Liaising between the CDSCO and the manufacturer

· Importation management

With a dedicated global delivery and operational centre in India, Freyr offers extensive knowledge on Indian Regulatory landscape. With a well-paved Regulatory strategy, Freyr provides end-to-end Regulatory services for pre- and post-marketing activities of Medical Devices.

Summary

Type of Device

Risk

Device Class

QMS Audit

Regulatory Pathway

IAA

Final Outcome

Non-Notified Device

NA

NA

NA

Listing of devices in SUGAM portal

Yes

Listing in database

Notified Device

Low Risk

A

Schedule 5 of MDR 2017 or

ISO 13485:2016 certification

Device Registration

Yes

Test / Manufacturing /Loan/Import License

Low - Moderate Risk

B

Moderate – High Risk

C

High Risk

D

Expertise

Freyr Expertise

  • Regulatory Intelligence and Due-Diligence services in India
  • Medical Device Classification and grouping strategy
  • Indian Authorized Agent (IAA) representation
  • SUGAM account creation and account management
  • Test License for Medical Devices and IVDs
  • Import License for Regulated Medical Devices and IVDs
  • Manufacturing License for Regulated Medical Devices and IVDs
  • Loan license for Regulated Medical Devices and IVDs
  • Listing of Non-Regulated Medical Devices
  • Manufacturing Site Registration
  • Compilation services for device documents and Device Master File (DMF) 
  • Liaison with the CDSCO, Central, and State Licensing Authorities
  • In-country Testing services
  • Post-Market Surveillance
  • AERB approval for Radiation Diagnostic Devices